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Prostaglandins Use Before Mirena IUD Insertion in Prev CS Women During Lactational Amenorrhea

Cairo University (CU) logo

Cairo University (CU)

Status

Unknown

Conditions

to Study the Estimate Difficulty of Insertion Mirena IUD With Use of Prostaglandins

Treatments

Drug: Misoprostol

Study type

Observational

Funder types

Other

Identifiers

NCT04646161
professor

Details and patient eligibility

About

This is a prospective randomized controlled study to determine the effect of prostaglandin intake before Mirena IUD insertion It was conducted at the Department of Obstetrics & Gynecology, Kasr El-Ainy Teaching Hospital, Faculty of Medicine, Cairo University,

Full description

The study aiming to measure the estimate difficulty of insertion of the Mirena IUD by using prostaglandins 2 hours before the procedure and the effect of prostaglandins to make this procedure easy with other side effects and complications as bleeding perforation, nausea, vomiting, failure of insertion and comparing them with a placebo group who didn't receive prostaglandins

Enrollment

400 estimated patients

Sex

Female

Ages

20 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 1- Women in lactational amenoeehea with pregnancy test negative 2- Women who had caesarean section within 6 monthes of IUD insertion 3- No medical disorders

Exclusion criteria

  • 1- Women in regular menses 2- Medical disorders 3- Nulligravida or muligravida with NVD 4- Women with history of Previous CS more than one CS 5- Any congenital uterine anomalies, fibroids and adenomysis 6- Chronic pelvic pain 7- Intrauterine adhesions 8- Spasmodic dysmenohrrea 9- Allergy to misoprostol

Trial design

400 participants in 2 patient groups

prostaglandins before iud insertion group
Description:
this group will receive 200 mcg prostaglandins in form of misoprostol 2 hrs before mirena iud insertion
Treatment:
Drug: Misoprostol
placebo group
Description:
this group will receive placebo tablet before mirena iud insertion

Trial contacts and locations

1

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Central trial contact

hadeer meshaal, assistant prof; hany saad, assisstant prof

Data sourced from clinicaltrials.gov

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